(1) Field of the Invention
The present invention relates generally to a container for holding prescription medicine in pill or capsule form, and in particular to a container incorporating features to reduce the risk of harm to the patient in the event that the prescription is erroneously filled.
(2) Description of the Prior Art
All too frequently, errors are made by pharmacists or their assistants in filling prescriptions. Some of these errors are caught by the patient who notices the difference in the medication compared to medication previously obtained for the same prescription. However, under certain circumstances, the patient may not notice the error. For example, the erroneous medication, e.g., a pill, and the correct pill may be similar in appearance, or the error may occur the first time that the prescription is being filled. In other instances, the patient may simply fail to notice the mistake because differences in size and/or color of the pills are difficult to detect, particularly if the patient has less than perfect vision.
Errors in the filling of prescriptions can arise from a variety of circumstances. In many instances, the error can be attributed to the inattention of the pharmacist, particularly during times when there is a need to fill a large number of prescriptions. Also, the error can be occasioned by the lack of experience of the pharmacist with the particular prescription, or the general lack of experience of the pharmacist""s assistant. Other errors can be caused by the similarity of unrelated pills in color and/or shape. Errors can also arise from name similarities, e.g., Feldene/Seldane, Lodine/Codeine, or Prilosec/Prozac.
Errors by pharmacists will continue to occur. Those errors that are not caught by the patient as least deprive the patient of the benefit of the prescribed medication. At worst, the errors can result in death or serious injury. In addition, malpractice errors can result in considerable expense to the negligent pharmacist, or his or her insurer.
Due to the large number of prescription drugs, elimination of pills with similar colors, shapes and/or names is mathematically impossible. In fact, the extent of the problem will increase over time as new drugs become available. Human error will also continue. Therefore, there is a pressing and increasing need for a means to detect erroneously filled prescriptions.
The present invention is directed to improved containers for prescription drugs, and in particular to improved prescription drug containers incorporating means to aid the pharmacist and the patient in noting when an error has been made in the filling of the prescription.
The present invention is particularly directed to prescription containers to the kind used to hold prescription medicines sold in solid form, e.g., pills, tablets, caplets, suppositories, or capsules. These medications in solid form will be referred to herein for convenience and brevity, as pills. Generally, these containers are comprised of a receptacle into which the pills are placed through an opening, a cap or cover attachable over the opening and a label that is affixed to the receptacle. It will be understood, however, that the concepts forming the basis of the present invention can also be applied to medications in non-solid forms, such liquids, ointments, or gels, etc., and to other receptacle configurations.
The receptacle is normally of a cylindrical shape, having a continuous side wall with continuous upper and lower edges, and a bottom wall or base extending across the lower edge of the side wall. The receptacle is normally threaded adjacent the upper edge of the side wall to receive a correspondingly threaded cap used to close the receptacle opening formed by the upper edge of the side wall.
The wall may be threaded on its outer surface, its inner surface, or both, depending upon the particular cap design. Additionally, the wall may include locking projections on its exterior surface adjacent the upper edge, forming part of a childproof locking mechanism. Usually, the wall and bottom are integrally molded from a transparent, colored plastic.
The cap is normally molded from an opaque plastic material and is designed to be secured over the receptacle opening. Usually, the cap is comprised of a planar top wall with a circular periphery, and a continuous integral side wall that extends downwardly from the periphery of the top wall. The side wall may be internally or internally threaded to join with the receptacle.
The cap may be simply threaded or screwed onto the top of the receptacle. In so-called childproof caps, the interior of the cap side wall is normally threaded and includes locking projections to join with external locking projections on the corresponding receptacle. These locking projections function in a known manner and are not per se a part of the present invention.
In some designs, the receptacle is internally and externally threaded. The cap used with these receptacles includes a first continuous wall designed to fit around the exterior of the receptacle. In addition, the cap includes a second continuous wall, integrally joined to one edge of the first wall by a horizontal flange, to fit into the interior of the receptacle. In this design, the cover will normally extend across the exterior edge of the second wall to enclose the receptacle contents.
When a prescription is to be filled, the pharmacist, or his or her assistant, selects a large container of pills corresponding to the medication to be prescribed, transfers the designated number of pills from the large container to a receptacle, and caps the receptacle with its matching cap. An instruction sheet may also be included on or in the receptacle. The pharmacist or assistant then types information about the prescription onto a label, and attaches the label to the wall of the receptacle.
Labels are normally pre-printed with standard information common to all prescriptions filled at the particular pharmacy, including the name, address and telephone number of the pharmacy. Information unique to the prescription, such as the patient""s name, doctor""s name, the name of the prescribed medicine, instructions for use, number of refills, etc., are then typed onto the label at the time the prescription is filled.
Historically, pre-printed labels were supplied in rolls, and the unique information was typed onto the label using a typewriter. Today, the unique information may typed onto the label using a computer equipped with conventional word processing software. However, most modern pharmacies use either a computer equipped with software especially designed to print labels, which may be a normal desktop computer, or a computer especially designed for this purpose. Output from the computer is sent to a conventional printer, such as an ink jet or laser printer, or a label printer especially designed to print labels.
The present invention is directed to two modifications of the above containers and the related procedures for their preparation that may be used alone or in combination to significantly increase the likelihood that the pharmacist or the patient will detect an error in filling the prescription in question. One of these improvements relates to an improved cap forming a part of this type of container, while the other improvement, which can be used alone or with the cap improvement, relates to an improved label.
With conventional prescription containers such as described above, the contents of the container is difficult to see since the receptacle, while usually transparent, is of a bronze or other color to protect the contents from deterioration caused by light. Additionally, the contents are at least partially hidden by the opaque container cap and the label covering most of the receptacle side wall. Thus, the patient, as well as the pharmacist, is prevented from seeing the container contents.
Ready identification of the container contents is further restricted by the size of the pills and the fact that any identification on the pills, such as the drug name, is in a small font, and may be impressed into the pill during manufacture so that the name is the same color as the pill. If the pharmacist could easily see the pills in containers that have been filled by others, such as his or her assistants, and if the patient could easily see the contents at the time of purchase, many of the errors could be caught before the pills are ingested.
Unlike prior art prescription container caps, the caps of the present invention facilitate viewing of the interior contents, by creating a separate pill chamber within the cap, with the chamber including a transparent covering so that the contents of the cap can be easily viewed. At the time the prescription if filled, the person filling the prescription places one pill from the prescription in the chamber.
Preferably, the cover is clear to facilitate viewing of the interior contents. However, a transparent covering of a bronze or other shading is also contemplated by the invention, so that the contents of the chamber can be protected from exposure to light. Additionally, the chamber top includes a magnifying lens, permitting the viewer to more easily read any indicia on the pill within the chamber. Use of UV blocking plastic as the material for the entire vial or at least the cap or cover is also contemplated.
UV light penetration can also be minimized by inverting the vial when it is place on the counter or other surface. If this procedure is used, a cap having an outer edge with a diameter greater than the diameter of the vial may be used for improved stability. In addition, the label may be attached upside down on the vial, e.g., with the bottom edge of the label toward the vial cap, to remind the user to invert the vial.
Thus, the cap is comprised of a transparent top cover through which the contents of the chamber can be viewed, and means for attaching the cap over the receptacle opening. Preferably, the transparent cover includes a magnifier. The cap preferably also includes a chamber beneath the transparent cover for holding a pill for viewing.
Alternatively, instead of positioning a magnifier within the cap, a conventional prescription vial or container cap can be used, and the magnifier can be positioned or formed in the bottom wall of the container transverse to the longitudinal axis of the vial. In this embodiment, a support wall can be positioned transversely across the vial above the bottom wall.
UV light penetration can also be minimized by covering the cap or the magnifying lens with a removable cover, which may be as simple as a peel off cover. However, in order to facilitate covering of the cap or magnifying lens when the lens is not being used, the UV protective covering is preferably hinged, so that it can be moved from over the lens during use, and then rotated or pivoted back into place. That is, the covering can be hinged at one edge to pivot upward, or to rotate along a horizontal plane.
For example, the cap can be formed of a continuous side wall having an upper edge and a lower edge, a lower cover extending across the side wall intermediate the upper and lower edges, threads on the side wall between the lower cover and the lower edge, and a detachable transparent top cover including a magnifier across the side wall.
With this configuration, a chamber is defined by the upper and lower covers and the continuous side wall. This chamber may be accessed by detaching, i.e., opening the top cover to insert a pill. The pill can then be viewed through the transparent top cover, with the details of the pill being magnified for easy identification.
The threads can be formed on the interior or exterior surface of the cap, depending upon the particular container design. In addition, the cap can include a component of a locking means to render the cap childproof, with the corresponding component of the locking means being located on the receptacle.
After reading this disclosure, other cap configurations will become apparent to one skilled in the art. The exact means for attaching the cap to the receptacle is not critical to the present invention, so long as the cap or end wall includes a magnifier, i.e., a transparent convex portion which increases the apparent size of the pill in the chamber when viewed through the magnifier, and preferably a pill chamber beneath the transparent covering to hold the pill.
Another aspect of the invention relates to the labeling of the prescription to reduce errors. In the present invention, labels for the prescription containers are prepared, as with the prior art, using a processor, e.g., a desktop computer, or a computer especially designed as a label printer. The label is operatively connected to a printer, which may be a standard ink jet, bubble or laser printer, or a printer especially designed to print labels.
The processor, like the prior art, also includes software to format the labels. Unlike the prior art, the software used in the present invention is especially written to recognize the names of drugs as the drug names are typed onto the labels, and includes a database comprised of graphic images of various drugs. The software is written to compare drug names as the names are typed onto the labels and select an image of a pill corresponding to the drug name. The software then instructs the printer to print a color image of the pill onto the label during printing.
The software may be word processing software that includes the graphic image database. As each letter of the drug name is typed, the software narrows the numbers of possibly correct images by selecting those images having identifying names that include the letters typed. The number of possible images is diminished each time a letter is typed, until only one possible image exists when the entire name has been typed. The software, upon receiving a print signal, then prints this remaining image onto the label at the time the textual matter is printed.
Various programs can be written to accomplish the above objective. For example, the word processing component of the software, the graphic database, and the linking instructions used to select the appropriate image based upon letters typed, can be written as a single software program. Alternatively, a conventional software program can be used, with auxiliary graphic image software being added to respond to the word processing software.
Also, the graphic image software can read the entire drug identifying word at the time the label is to be printed, instead of one letter at a time as the information is being typed into the processor on the keyboard. Instead of typing the name of the drug, the operator can use a conventional pull-down menu or other menu that lists the drug names. The operator will then select the appropriate name from the menu, with the graphic image software being responsive to the drug name selected.
Preferably, the software will also display the image of the medication or pill on the computer screen when the pill is selected. Thus, the operator will be able to view the pill image and the typed information together before the label is printed. Since the software automatically selects the pill image at the time the name of the pill is typed into the processor, errors are virtually eliminated. If a typographical error is made, the software will not display or print a pill image, unless the typographical error corresponds exactly to the name of a stored pill image.
In this latter instance, which could occur if the operator intentionally types in the wrong drug name, the image of a pill would be displayed and printed. However, the operator, who will normally be familiar with the image of the desired pills, will be alerted by the pill image that an error has been made. In addition, the ability of the operator, pharmacist and/or patient to view the actual pills in the vial along with the pill image on the label serves to eliminate even this unlikely error.
In order to facilitate comparison, the image of the pill is preferably of the same size and color as the actual pill. However, the image can be larger or smaller than the actual pill. Additional information or instructions can also be printed, such as the indicia, name, or other identifying information that is printed onto, or impressed into, the pill. Also, wording or colors can be used to draw the user""s attention to the pill image. For example, a word such as VERIFY can be added to the label, and as part of the label can be printed in red or another contrasting color.
Thus, the completed label, in addition to the name of the drug and other general and specific information of the type normally found on a prescription label, will also include an image of the pill present in the labeled container. The patient, before taking a pill, only needs to compare the actual pill with the pill image on the label to determine if the pills match. If so, the patient can be confident that the name of the pill on the label is the same as the pill in the container.
Therefore, in this aspect of the invention, the complete container will be comprised of a receptacle containing the given medication, a cap to close the receptacle, and a label attached to the receptacle, the label having printed thereon the name of the given medication and an image corresponding to the medication.
When combined with the above-described cap in another aspect of the invention, the final product will be comprised of a receptacle containing a plurality of a given pill; a cap to close the receptacle, the cap including a chamber with a transparent cover containing one of the given pills; and a label attached to the receptacle, the label having printed thereon the name of the given pill and an image of the pill. Preferably, the transparent cover is in the shape of a magnifying lens to facilitate comparison of the pill in the chamber with the image of the pill on the label.
When a prescription is correctly filled, the pharmacist or assistant will select the supply container containing the prescribed drug, and transfer the prescribed number of pills to a receptacle, placing one on the prescribed pills in the chamber of the cap. The name of the prescription drug and other related information will be entered into the computer software, e.g., by typing the information with the keyboard of a processor, selecting the information from a menu or other database source, or a combination of methods, for printing onto a label.
As the name of the drug is entered, the software will compare the drug name with a database of medication or pill graphic images, and select the image corresponding to the name of the typed drug. When the signal is sent from the processor to the printer, the printer will also be instructed to print a color image of the pill or other medication onto the label, e.g., near one corner of the label. An image of the pill may also be displayed on the computer monitor prior to printing of the label.
The same steps will be followed if the pharmacist or assistant selects the wrong supply container. However, when the product is complete, the pharmacist, or the patient, needs only to compare the actual pill housed in the cap chamber with the image of the pill on the label to realize that an error has been made. Additionally, the patient can compare the contents of the receptacle with the label image at the time the medication is consumed. For example, the patient can hold a pill in his or her hand, and view the pill with the magnifying cap, to compare the pill and image.
The prescription labels can be individual rectangular labels, or a roll of labels that are attached to each other, or to a common base. However, the present invention also contemplates the use of labels that can be sized to fit vials of different diameters and heights, with the entire wall of the vial being covered by the label to prevent UV light penetration through the vial wall. With the use of this label, and a covering over the magnifier, the entire vial can be made of clear plastic.
Vials of different heights and/or diameters are ordinarily used by a pharmacy to accommodate prescriptions of a different number of pills, and pills of different sizes. Thus, a prescription for a large number of pills and/or pills of a large size would be placed into a large container, while a prescription for a smaller number of pills and/or pills of a relatively smaller size, would be placed in a smaller container.
In accordance with the present invention, a label having vertical and/or horizontal perforations in addition to the normal separating perforations is used. When the label is to be applied to a large container, the entire label is printed and applied. However, when the label is to be applied to a small container, the information is printed on a part of the label, and the unused portion of the label, vertically and/or horizontally, is detached prior to attachment of the label to the vial.
Selection of a label of the correct size, and thereby printing of the label information onto the appropriate portion of the label is achieved with software that selects the position of the print based upon the identity of the drug and the size of the prescription entered by the operator. The software used for this purpose can form a part of the software discussed above, with the printing position being determined by the software at the same time the correct pill image is selected.
For example, if the operator enters the name of a drug having a relatively large pill dimension and/or a larger number of pills, the software will determine that a large vial will be required, and the information can be printed on the entire label. However, if the operator enters the name of a drug having a relatively small pill dimension and/or a smaller number of pills, the software will limit the printing to the smaller dimension of the label. In this latter instance, the operator can tear off the unused horizontal and/or vertical sections of the label before applying the label to the vial.
The preceding and other aspects of the present invention will become apparent to those skilled in the art after a reading of the following description of the preferred embodiment.